NCT07099313Recruiting
Association of Prophylactic Treatment With Treatment Burden and Psychosocial Variables in Patients With Hemophilia
Association of Prophylactic Treatment With Treatment Burden, Self-efficacy, Adherence, Sleep Quality, and Locus of Control in Patients With Hemophilia; an Ambispective Cohort Study
Source: ClinicalTrials.gov · Last updated 5 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Introduction: Hemophilia is a congenital coagulopathy characterised by recurrent haemarthrosis, leading to chronic arthropathy and functional impairment. Prophylactic treatment with extended half-life (EHL) or short half-life (SHL) clotting factor concentrates is the most effective strategy for preventing these episodes. EHL products have demonstrated haemostatic efficacy, with a lower frequency of infusions, potentially reducing the treatment burden, although their psychosocial impact has not yet been sufficiently explored. Objectives: To evaluate the association between perceived treatment burden and psychosocial variables such as self-efficacy, adherence, sleep quality and health locus of control, depending on the type of treatment received (EHL or SHL). Methods. Multicentre, ambispective cohort study. A total of 114 patients with haemophilia A or B undergoing EHL or SHL prophylactic treatment will be included. The primary variable will be treatment burden (Treatment Burden Questionnaire). Secondary variables will be perceived self-efficacy (General Self-Efficacy Scale), adherence (Torres scale), sleep quality (Pittsburgh Sleep Quality Index), treatment adherence (Torres Questionnaire) and health locus of control (Multidimensional Health Locus of Control). Potential confounding variables will include sociodemographic data (age, educational level, living arrangements) and clinical data (number of weekly infusions, type of hospital). Expected results: Patients treated with extended-half-life products are expected to report lower treatment burden, higher self-efficacy and better sleep quality, regardless of sociodemographic or clinical factors.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 114 (estimated)
- First submitted
- 25 Jul 2025
- Start date
- 31 Jul 2025
- Primary completion date
- 13 Sept 2025
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Diseases
- Haemophilia
- NCT number
- NCT07099313
What you commit to
- Study type: Observational
- Planned participants: 114
- From 31 Jul 2025 to the primary completion date, 13 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have developed inhibitors or antibodies to FVIII or FIX concentrates.
- People with a concomitant diagnosis of other serious or disabling chronic diseases (neurological, oncological, severe psychiatric or rheumatological) that may interfere with the perceived burden of treatment, sleep quality, functionality or perception of self-efficacy.
Other
- Patients with cognitive, linguistic or sensory impairments that prevent them from correctly understanding and completing the questionnaires.
- Patients who are participating in clinical trials or intensive monitoring programmes that may alter their perception of the treatment and generate biases in the evaluation.
Who the study is looking for
- Patients over 18 years of age.
- Patients with a medical diagnosis of hemophilia A or B.
- Patients who, regardless of disease phenotype (mild, moderate or severe), are receiving prophylactic treatment with recombinant or plasma clotting factor concentrates, either short half-life or extended half-life.
- Patients must have maintained the same treatment regimen (SHL or EHL) continuously for at least six months prior to participation.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad de Oviedo Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.